Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

Nourhan M.Aly

Status and phase: Completed; Phase 2

Conditions: Dental Anxiety

Treatments: Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX); Drug: Midazolam group (MDZ); Drug: Dexmedetomidine group (DEX)

Study type: Interventional

Funder types: Other

Identifiers

NCT03827408

IORG0008839

Details and patient eligibility

About

The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Full description

Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option.

Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.

Enrollment: 72 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range 4-6 years
• Frankl scale score 2.
• ASA I or II physical status.
• Dental intervention under local anesthesia not requiring more than 30 minutes.
• No previous dental experience.
• Parent/guardian"s written consent.

Exclusion criteria

• Dental treatment indicated under general anesthesia.
• Presence of facial deformities.
• History of neurological or cognitive alterations.
• Mouth breathers.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups

Midazolam group (MDZ)

Active Comparator group

Description:

Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.

Treatment:

Drug: Midazolam group (MDZ)

Dexmedetomidine group (DEX)

Experimental group

Description:

Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.

Treatment:

Drug: Dexmedetomidine group (DEX)

Combination of Midazolam and Dexmedetomidine (MDZ/DEX)

Experimental group

Description:

Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.

Treatment:

Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)